Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm (ATI-CL13)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Agile Therapeutics
ClinicalTrials.gov Identifier:
NCT01236768
First received: November 5, 2010
Last updated: January 28, 2013
Last verified: January 2013

November 5, 2010
January 28, 2013
October 2010
June 2011   (final data collection date for primary outcome measure)
Pregnancy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01236768 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm
An Open-Label, Randomized, Phase 3 Study of the Contraceptive Efficacy and Safety of Agile Transdermal Contraceptive Delivery System (TCDS) in Comparison to an Oral Contraceptive Containing 150 Mcg Levonorgestrel And 30 Mcg Ethinyl Estradiol

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • Drug: Study Drug AG200-15, Contraceptives, Hormonal
    Contraception; TCDS is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
  • Drug: Levora, Contraceptives, Oral, Hormonal
    one tablet will be taken each day for a 28 day cycle.
  • Experimental: AG200-15
    Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)
    Intervention: Drug: Study Drug AG200-15, Contraceptives, Hormonal
  • Active Comparator: Levora
    oral contraceptive containing 150mcg of LNG and 30mcg of EE
    Intervention: Drug: Levora, Contraceptives, Oral, Hormonal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
407
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • sexually active women requesting contraception
  • Regular menses every 24 - 35 days
  • In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion Criteria:

  • Known or suspected pregnancy
  • Lactating women
  • Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
  • Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
  • Use of other contraceptive methods than study medication
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01236768
ATI-CL13
No
Agile Therapeutics
Agile Therapeutics
Not Provided
Study Director: Marie Foegh, MD Agile Therapeutics
Agile Therapeutics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP